Teleflex Arrow EZ-IO Instructions For Use

EZ-IO
Product InformatIon
INTRAOSSEOUS VASCULAR ACCESS
Product InformatIon
BODY
DESCRIPTION:
Drive Battery
• The EZ-IO® Power Driver is a sealed,
Shaft Indicator
TRIGGER
hand-held, lithium battery powered
medical device.
SEALED
LITHIUM
BATTERIES
PRODUCT INFORMATION:
• Driver Ref. numbers: 9040 (Tactical); 9058 (Civilian).
• Applied Parts: EZ-IO® Intraosseous Vascular
Lanyard
Access Needles – 15 mm; 25 mm; 45 mm.
Attachment
Point
SAFETY INFORMATION:
• Indications, contraindications, warnings, precautions, and other safety information are
contained in the Instructions for Use for the EZ-IO® Intraosseous Vascular Access System.
• Please consult the Instructions for Use for the EZ-IO® Intraosseous Vascular Access
System before applying. If there are questions, or if this information sheet is missing,
immediately contact your local Teleflex sales representative.
• Additional product information can be found at ArrowEZIO.com.
• As with any emergency medical device carrying a backup is a strongly advised protocol.
IMPORTANT INFORMATION FOR USERS:
In order for EZ-IO® Intraosseous Vascular Access System products to perform properly, the
following conditions are recommended. Failure to comply with these conditions will void any
applicable warranties.
• Use this product only in accordance with this manual and applicable product labeling.
• Adjustments, modifications, technical maintenance or repairs are not allowed.
• Do not connect this product or its components to products not recommended by Teleflex.
• Use only EZ-IO® Intraosseous Vascular Access needle sets with this product.
• Visually inspect driver for cracks and sharp corners before use.
• Avoid spilling fluids on any part of this product.
• Do not use excessive force during insertion. Let the EZ-IO® Power Driver do the work.
STORAGE:
• The EZ-IO® Power Driver and accessories may be stored at temperatures between
-20°C to 50°C (-4°F to 122°F).
• Expected shelf life for the EZ-IO® Power Driver is 10 years or approximately
500 insertions.
• Life expectancy is dependent on actual usage (bone density and average insertion
time), storage, and frequency of testing.
• When storing the Vascular Access Pak (VAP) remove the trigger guard to prevent
accidental activation of the EZ-IO® Power Driver.
EZ-IO
INTRAOSSEOUS VASCULAR ACCESS
BATTERY INFORMATION:
• Drivers are sealed and not intended to be opened.
• Batteries are not replaceable.
INDICATORS & ALERTS:
• EZ-IO® Power Driver LED will be solid green when trigger is activated and has sufficient power.
• EZ-IO® Power Driver LED will blink red when the trigger is activated and has only 10% of
battery life remaining.
• Purchase and replace the EZ-IO® Power Driver when the red LED begins blinking.
CARE AND CLEANING:
1. Maintain BSI or PPE precautions.
2. Wipe entire exterior surface of EZ-IO® Power Driver with soft, clean moistened cloth. Use soft
bristled brush to remove any visible soil.
3. Spray exterior surface with anti-microbial solution following the solution manufacturer's
specific recommendations.
4. Gently wipe exterior surfaces with gauze pads until visible debris is removed.
5. Clean and manipulate trigger using cloth moistened with anti-microbial solution.
6. Using sterile swabs, moisten with anti-microbial solution, gently clean inside opening around
metal drive shaft.
7. After cleaning, inspect to ensure no visible debris remains, and no damage has occurred.
8. Dry driver with a soft, clean cloth and return to appropriate location.
Do not immerse or use excessive amount of liquid when performing cleaning and disinfecting.
In the unlikely event of a driver failure, remove the EZ-IO® Power Driver, grasp the needle set by
hand, and advance the needle set into the medullary space while twisting the needle set.
If your clinical environment requires sterilization, the EZ-IO® Power Driver can be sterilized
using the STERRAD® 100S System. STERRAD® Systems are products of ©ADVANCED STERILIZATION
PRODUCTS, Division of Ethicon Inc., a Johnson & Johnson company.
WARNING: No modification of this equipment is allowed.
ArrowEZIO.com
EMERGENCY NUMBER:
1.800.680.4911
Customer Service: 1.866.479.8500
Manufactured for:
Teleflex Medical
IDA Business & Technology Park,
Dublin Rd, Athlone,
Co. Westmeath, Ireland
At the completion of the
This device is restricted
Power Driver ' s service
for sale by or on order
life, proper disposal is
of a physician.
the responsibility of the
institution or service
4001639
Serial Number
(directive 2012/19/EU). SN
Degree of protection The System Conforms
Consult Instructions
against electric shock to the Medical Device
For Use
BF Applied part. Directive (93/42/EEC)
©
2014 all rights reserved. Arrow®, EZ-IO Intraosseous Vascular System®,
EZ-Stabilizer™, and EZ-Connect® are trademarks of Teleflex Inc.
8047 Rev 05 (06/2015)
EZ-IO
®
POWER DRIVER
Instructions for Use